A Study to Evaluate the Pharmacokinetics (behavior of drug inside the body), Pharmacodynamics (biochemical and physiological effects of drugs), and Safety of AZD7442 in children aged = 29 Weeks Gestational Age (measure of the age of a pregnancy) to < 18 Years
- Conditions
- COVID-19MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2021-006056-13-DE
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 100
•Participant must be aged = 29 weeks to < 18 years of age.
•Participant must weigh a minimum of 1.5 kg.
COHORT 1
•Increased risk of severe COVID-19 because of immunocompromised state or one or more comorbid conditions that increase the risk of severe COVID-19.
•Medically stable (disease not requiring significant change in therapy or hospitalization for worsening disease during the one month prior to enrollment).
•A negative RT-PCR test collected = 3 days before Day 1 or a negative rapid SARS-CoV-2 antigen test at screening.
•No COVID-19 symptoms prior to enrollment within 10 days of dosing.
• Increased risk for SARS-CoV-2 infection.
COHORT 2
•Increased risk of severe COVID-19 because of immunocompromised state or one or more comorbid conditions that increase the risk of severe COVID-19.
•Medically stable (disease not requiring significant change in therapy or hospitalization for worsening disease during the one month prior to enrollment).
•A positive RT-PCR test collected = 3 days before Day 1 or a positive rapid SARS-CoV-2 antigen test at screening.
•Symptomatic participants must be dosed with IMP no more than 7 days from the self-reported date of first reported sign/symptom.
•= 92% oxygen saturation at rest within 24 hours before Day 1 unless the participant is a regular receiver of chronic supplementary oxygen for a lung condition.
COHORT 3
•Participants hospitalized with COVID-19 between the onset of symptoms and dosing AZD7442 of = 7 days.
•A positive RT-PCR test collected = 3 days before Day 1 or a positive rapid SARS-CoV-2 antigen test at screening.
•Spontaneous blood Alanine Aminotransferase (ALT)/Aspartate Transaminase (AST) levels = 5 times the ULN.
•Glomerular Filtration Rate (GFR) = 30 mL/min.
ROUTE OF ADMINISTRATION
- Participants will receive IM AZD7442 unless they meet any of the following criteria for IV
administration:
•Severe COVID-19.
•Contraindication of intramuscular (IM) dose due to thrombocytopenia, coagulation defects or any other condition that would compromise the absorption of AZD7442 or safety of the participant.
•A central intravenous (IV) line.
Physician considers IV the appropriate route.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
MEDICAL CONDITIONS
•Cohort 1: Significant infection or other acute illnesses including fever on or the day prior to or day of receiving AZD7442.
•History of SARS-CoV-1 or Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
•Cohorts 1 and 2: Current need for immediate medical attention in an emergency room service or current need for hospitalization.
•Mechanical ventilation or extracorporeal membrane oxygenation requirement for COVID-19.
•History of allergic or reaction to any component of the study drug formulation.
•History of hypersensitivity, injection/infusion-relation reactions or severe adverse reactions following administration of a mAb.
•Co-morbidity requiring surgery within 7 days prior to study entry or is deemed life-threatening within 30 days prior to study entry.
THERAPY PRIOR ENROLLMENT
•Prior receipt of convalescent COVID-19 plasma/sera or hyperimmune globulin therapy.
•Prior receipt of mAb/biologic indicated for the prevention of SARS-CoV-2, treatment of COVID-19, or expected receipt during the period of study follow-up.
•Prior receipt of a COVID-19 vaccine = 14 days before screening or plan to receive a COVID-19 vaccination = 14 days after IMP administration at study Visit 1.
OTHERS
•History of alcohol or drug abuse within the past 2 years.
• Vulnerable persons (ward of the state, kept in detention).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method